F-BEVAR vs Open Surgery for Complex Abdominal Aortic Aneurysm

February 9, 2022 updated by: TINELLI GIOVANNI, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Propensity Matched Comparison of Fenestrated Endovascular Aneurysm Repair and Open Surgical Repair for Complex Abdominal Aortic Aneurysms.

The aim of the present study was to investigate outcomes of a propensity matched series of patients treated with F-BEVAR and open surgery repair for complex abdominal aortic aneurysm in two aortic high-volume centres.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This retrospective study analyzes the long-term outcomes of a propensity-matched cohort of patients with complex abdominal aortic aneurysm prospectively collected between January 2010 and June 2016 from the Aortic Center of Lille (Lille, France) and the Unit of Vascular Surgery of Policlinic Gemelli (Rome, Italy).

Patients were observed with regular postoperative appointments. The long-term imaging follow-up consisted in a yearly computed tomography angiography in the F-BEVAR group; and yearly abdominal ultrasound examination and 5-year computed tomography angiography were performed in the open surgery repair group. In case of abnormal renal function (eGFR<60 mL/min/1.73 m2), the patient underwent computed tomography without contrast associated to a contrast-enhanced ultrasound examination in both groups. Laboratory data with evaluation of renal function by estimated glomerular filtration rate (eGFR), were completed at three, six, and 12 months, and yearly thereafter. Survival assessment was completed after general partitioner's, patients' or patient siblings' contact by phone.

Study Type

Observational

Enrollment (Actual)

278

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

A total of 157 patients, referred to the Aortic Center of Lille (France), underwent F-BEVAR treatment; 119 patients, referred to the Policlinic Gemelli in Rome (Italy), concurrently underwent OSR.

Description

Inclusion Criteria:

  • juxtarenal abdominal aortic aneurysms
  • pararenal abdominal aortic aneurysms
  • suprarenal abdominal aortic aneurysms
  • type IV thoracoabdominal aneurysms

Exclusion Criteria:

  • extent I to III thoracoabdominal aneurysms
  • ruptured o symptomatic aneurysms
  • dissections or connective tissue disorder aneurysms.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
F-BEVAR
Patients with complex abdominal aortic aneurysm who underwent fenestrated and branched endovascular aortic repair (F-BEVAR) at the Aortic Center of Lille (ACL; Lille, France).
Procedure: Fenestrated and branched endovascular aortic repair (F-BEVAR)
Fenestrated and branched endovascular aortic repair (F-BEVAR)
OPEN SURGERY REPAIR
Patients with complex abdominal aortic aneurysm who underwent open surgery repair the Unit of Vascular Surgery of Policlinic Gemelli (FPUG; Rome, Italy).
Procedure: Open repair
Open surgery for complex abdominal aortic aneurysm

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall mortality
Time Frame: Through study completion, an average of 5 year
All cause death
Through study completion, an average of 5 year
Aortic-related mortality
Time Frame: Through study completion, an average of 5 year
Any death related to the initial procedure.
Through study completion, an average of 5 year
Chronic renal decline during follow-up
Time Frame: Through study completion, an average of 5 year
Chronic renal decline was defined in patients with normal (stage 1-2) preoperative renal function as a reduction in the eGFR to <60 mL/min/1.73 m2 during follow-up. In patients with abnormal function (stages 3 and 4) preoperatively, it was defined as an eGFR reduction of >20% or de novo dependence on permanent renal replacement therapy.
Through study completion, an average of 5 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Aortic-related reintervention
Time Frame: Through study completion, an average of 5 year
All secondary interventions related to the initial procedure or to the endograft and its target vessels during follow-up
Through study completion, an average of 5 year
Target vessel occlusion
Time Frame: Through study completion, an average of 5 year
Complete obstruction of the artery with no evidence of flow identified on any follow-up CT scan or duplex ultrasound.
Through study completion, an average of 5 year
Clinical failure
Time Frame: Through study completion, an average of 5 year
Death from complications of the initial operation or a secondary intervention, aortic aneurysm rupture, aortic conversion to open surgical repair, persistent type I or III endoleak, sac expansion >5 mm, device migration >10mm, infection or thrombosis in the F-BEVAR group and death, graft infection or thrombosis or para-anastomotic aneurysm in the open group.
Through study completion, an average of 5 year
Proximal aorta degeneration Proximal aorta degeneration
Time Frame: Through study completion, an average of 5 year
Diameter increase >5 mm within 5 cm above the ostium of the more proximal target vessel for the endovascular group and 5 cm above the proximal anastomosis for the open group
Through study completion, an average of 5 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Collaborators

Centre Chirurgical Marie Lannelongue

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (ACTUAL)

January 31, 2018

Study Completion (ACTUAL)

January 1, 2022

Study Registration Dates

First Submitted

January 31, 2022

First Submitted That Met QC Criteria

February 9, 2022

First Posted (ACTUAL)

February 21, 2022

Study Record Updates

Last Update Posted (ACTUAL)

February 21, 2022

Last Update Submitted That Met QC Criteria

February 9, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1843

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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